HEMImprove 1.0 in Children and Adolescents With Unilateral Cerebral Palsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HEMImprove APP, exercises to upper limb.
- Who it may be relevant to
- Registry conditions: Unilateral Cerebral Palsy. Basic parameters: 12 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
"Efficacy and Usability of HEMImprove 1.0 Gamified Mobile Application for Upper Limb Rehabilitation in Adolescents With Unilateral Cerebral Palsy: A Randomized Controlled Trial"
Overview
This study aims to evaluate the effectiveness and usability of HEMImprove 1.0, a gamified mobile application designed to improve upper limb motor function in adolescents with unilateral cerebral palsy. Participants will be randomly assigned to an intervention group using the app or a control group performing conventional home exercises. The intervention will last four weeks, with assessments before and after the intervention to measure motor function, motivation, and quality of life improvements.
Interventions
- Other HEMImprove APP
Experimental Group: Use HEMImprove 1.0 mobile app at home for 30 minutes/session, 5 days/week, for 4 weeks. Exercises tailored progressively with avatar guidance. Control Group: Perform conventional home exercises guided by printed manual with instructions and images, matching frequency and duration of intervention group. - Other exercises to upper limb
The patients will do the same exercises than the experimental group, without APP and using the same dosage
Primary outcome measures
- Assisting Hand Assessment [Time frame: baseline, immediately after the intervention, 3 months after intervention]
- Melbourne Assessment v 2.0 MA2 [Time frame: baseline, immediately after the intervention, 3 months after intervention]
- Nine hole Test [Time frame: baseline, immediately after the intervention, 3 months after intervention]
Secondary outcome measures (2)
- User satisfaction and usability measured through structured Likert-scale questionnaires post-intervention. [Time frame: From the recruitment to the follow-up]
- Qualitative data from semi-structured interviews analyzing user experience. [Time frame: from the recruitment to the end of the treatment]
Eligibility criteria
Inclusion criteria
- Adolescents aged 12 to 18 years diagnosed with unilateral cerebral palsy.
- Ability to use the mobile app independently or with minimal assistance.
- Informed consent provided.
Exclusion criteria
- Severe cognitive impairment.
- Recent upper limb surgery (within 6 months).
- Recent botulinum toxin treatment (within 3 months).
- Other neurological or orthopedic disorders affecting upper limb function.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07041944 · HEMImprove-APP · FEDER